Intra-abdominal Hypertension in Critically Ill Patients

The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.

Study Overview

• Status: Completed
• Conditions: Intra-Abdominal Hypertension; Abdominal Compartment Syndrome
• Intervention / Treatment: Other: No intervention

Detailed Description

Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.

• Study Type: Observational
• Enrollment (Anticipated): 286

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6K 1C2
      • Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults (>18 years of age) admitted to the intensive care unit at Victoria Hospital, London, Ontario who have a Foley catheter in-situ

Description

Inclusion Criteria:

• Foley catheter in-situ on admission

Exclusion Criteria:

• Contra-indication to bladder pressure measurement
• Home service asked that patient is not included
• Death within 24 priors of admission before bladder pressure measured
• No bladder pressure performed within 24 hours of admission
• Consent refused or unable to be obtained (lack of SDM, patient unable to provide)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elevated Intra-abdominal Pressure; Patients with intra-abdominal pressure > 12 mmHg at any time throughout admission	Other: No intervention
Normal Intra-abdominal Pressure; Patients with intra-abdominal pressure < 12 mmHg throughout admission	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	As measured prospectively by patient death in the ICU	While patient in-hospital, expected stay one week on average

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Measured prospectively from date of admission to ICU to death, or discharge from ICU	While patient in-hospital, expected stay one week on average
Abdominal decompression	Midline laparotomy for abdominal compartment syndrome	While patient in-hospital, expected stay one week on average

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Kelly N Vogt, MD, Western University

Publications and helpful links

General Publications

• Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): January 30, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): August 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Hypertension; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: WesternUCanada